HealthyPhase 1NCT02042729
A Phase 1 Comparative Study of E2022 Current and New Patch Formulations
A Phase 1 study testing E2022- Current Formula Tape and E2022- New Formula Tape in people with Healthy, run by Eisai Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to investigate the safety and pharmacokinetics of new patch formulation (tape) of E2022 by conducting patch test. Read more about this study
- Who is it for?
- Ages 20 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- E2022- Current Formula Tape and E2022- New Formula Tape
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2012to Dec 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoker or not smoking for 4 weeks or longer before study treatment
- BMI at screening is greater than or equal to 18.5 kg/m2 or less than 25.0 kg/m2
- With written informed consent
- Given full explanation of this study and is willing to and able to comply with study requirements.
Who cannot join
- (Cohort 1 and 2):
- Have a disorder which affects the evaluation of study drug such as psychiatric, gastrointestinal, hepatic, renal, respiratory, endocrinological, hematological, neurological, or cardiovascular system, or congenital metabolic abnormality
- Have a clinically significant abnormality or organ dysfunction
- Have a history of allergy to drug or food requiring medical treatment or seasonal allergy at screening
- Have a history or complication of contact dermatitis or atopic dermatitis
- Have hairy back or have shaved within 4 weeks before study treatment
Show all 15Show fewer
- Have a skin disease (e.g., eczema, dermatitis, dyschromatosis), or skin damage (e.g., injury, scar, or sun burn) which may affect skin assessment
- Have a history or suspected to have drug or alcohol dependence, or positive for urine drug screen at baseline or a day before screening
- Have had caffeine-containing drink or food, or alcohol within 72 hours before study treatment
- Have used liquid product (including cosmetics), or applied patch, tape, or bandage on the back within 4 weeks before study treatment
- Had hard exercise at least 5 days a week or a 1-hour or longer hard exercise within 2 weeks before study treatment
- (Only Cohort 2):
- Meet QTc of greater than 450 milliseconds at screening or immediately before study treatment
- Had nutrients, herb preparations (e.g. oriental medicine), other food or drink (e.g., grapefruit-containing juice) which may affect the activity of drug-metabolizing enzyme or transporter within 2 weeks before study treatment
- Had St. John's Wort-containing preparation within 4 weeks before Period 1 application
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the safety and pharmacokinetics of new patch formulation (tape) of E2022 by conducting patch test.
- Conditions
- Healthy
- Being tested
- E2022- Current Formula Tape, E2022- New Formula Tape, E2022 Matching Placebo- Current Formula Tape, E2022 Matching Placebo- New Formula Tape
- Keywords
- volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2022- Current Formula TapeDrug
Cohort I: E2022 current formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test.
Cohort II: E2022 current formula tape administered to skin application site and evaluated for 20 days.
E2022- New Formula TapeDrug
Cohort I: E2022 new formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test.
Cohort II: E2022 new formula tape administered to skin application site and evaluated for 20 days.
E2022 Matching Placebo- Current Formula TapeDrug
Also called Cohort I: E2022 Matching Placebo current formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test.
E2022 Matching Placebo- New Formula TapeDrug
Also called Cohort I: E2022 Matching Placebo new formula tape administered on a skin application site and evaluated for
| Study group | Role | What they receive |
|---|---|---|
| E2022- Tape Formulation | Experimental | Not described Receives: Drug: E2022- Current Formula Tape |
| Matching Placebo E2022 | Placebo comparator | Matching Placebo Receives: Drug: E2022 Matching Placebo- Current Formula Tape |
| E2022- New Formulation | Active comparator | Not described Receives: Drug: E2022- New Formula Tape |
| Placebo E2022- New Formulation | Placebo comparator | Matching Placebo Receives: Drug: E2022 Matching Placebo- New Formula Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Measured: 10 days (Cohort I) and 40 days (Cohort II)
Frequency of Adverse Events
Measured: 10 days (Cohort I) and 40 days (Cohort II)
Secondary outcomes (3)
Pharmacokinetic Parameter: Cmax
Measured: 40 days (Cohort II)
Pharmacokinetic Parameter: Tmax
Measured: 40 days (Cohort II)
Pharmacokinetic Parameter: AUC
Measured: 40 days (Cohort II)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startAug 2012
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hidetaka Hiramatsu, Study director, Eisai Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042729
- Sponsor's protocol ID
- E2022-J081-006
- Status last verified
- Feb 2014
- First submitted
- 21 Jan 2014
- Last updated
- 21 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Comparative Study of E2022 Current and New Patch Formulations
- ClinicalTrials.gov ID
- NCT02042729
- Acronym / sponsor ID
- E2022-J081-006
- Conditions
- Healthy
- Keywords
- volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the safety and pharmacokinetics of new patch formulation (tape) of E2022 by conducting patch test.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| E2022- Tape Formulation | Experimental | Drug: E2022- Current Formula Tape |
| Matching Placebo E2022 | Placebo comparator | Drug: E2022 Matching Placebo- Current Formula TapeMatching Placebo |
| E2022- New Formulation | Active comparator | Drug: E2022- New Formula Tape |
| Placebo E2022- New Formulation | Placebo comparator | Drug: E2022 Matching Placebo- New Formula TapeMatching Placebo |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Non-smoker or not smoking for 4 weeks or longer before study treatment
- BMI at screening is greater than or equal to 18.5 kg/m2 or less than 25.0 kg/m2
- With written informed consent
- Given full explanation of this study and is willing to and able to comply with study requirements.
Key exclusion criteria (15 listed)
- Have a disorder which affects the evaluation of study drug such as psychiatric, gastrointestinal, hepatic, renal, respiratory, endocrinological, hematological, neurological, or cardiovascular system, or congenital metabolic abnormality
- Have a clinically significant abnormality or organ dysfunction
- Have a history of allergy to drug or food requiring medical treatment or seasonal allergy at screening
- Have a history or complication of contact dermatitis or atopic dermatitis
- Have hairy back or have shaved within 4 weeks before study treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E2022- Current Formula TapeCohort I: E2022 current formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test. Cohort II: E2022 current formula tape administered to skin application site and evaluated for 20 days. | Drug | E2022- Tape Formulation |
| E2022- New Formula TapeCohort I: E2022 new formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test. Cohort II: E2022 new formula tape administered to skin application site and evaluated for 20 days. | Drug | E2022- New Formulation |
| E2022 Matching Placebo- Current Formula TapeAlso: Cohort I: E2022 Matching Placebo current formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test. | Drug | Matching Placebo E2022 |
| E2022 Matching Placebo- New Formula TapeAlso: Cohort I: E2022 Matching Placebo new formula tape administered on a skin application site and evaluated for | Drug | Placebo E2022- New Formulation |
Primary outcome
Number of Adverse Events
Time frame: 10 days (Cohort I) and 40 days (Cohort II)
Frequency of Adverse Events
Time frame: 10 days (Cohort I) and 40 days (Cohort II)
3 secondary outcomes
Pharmacokinetic Parameter: Cmax
Time frame: 40 days (Cohort II)
Pharmacokinetic Parameter: Tmax
Time frame: 40 days (Cohort II)
Pharmacokinetic Parameter: AUC
Time frame: 40 days (Cohort II)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2014.
Related trials for Healthy
Active, not recruitingObservational study
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Spinal Cord Injuries, Traumatic Spinal Cord Injury
Recruiting
Effects of a Hemp Seed-based Product on Appetite and Health Parameters
Healthy
RecruitingPhase 1
A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH
Metabolic Dysfunction-Associated Steatohepatitis
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers
Not yet recruiting
Stearic Acid and Endothelial Function
Healthy Middle-aged Subjects, Obesity & Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hidetaka Hiramatsu study director
Eisai Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E2022- Current Formula Tape and E2022- New Formula Tape in people with Healthy, run by Eisai Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: 10 days (Cohort I) and 40 days (Cohort II)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2014.